An observational study in Urothelial Bladder Carcinoma, Bladder Carcinoma and Non-Muscle-Invasive Bladder Cancer (NMIBC), sponsored by Assiut University. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Assiut University · Observational
Bladder cancer is a significant global and local health concern, and predicting how aggressive a patient's tumor will behave is critical for guiding treatment. This observational study aims to evaluate two specific microscopic features of urothelial bladder carcinoma to see if they can reliably predict patient outcomes: the depth of early tumor invasion (T1 substaging) and the presence of small clusters of cancer cells at the tumor's edge (Tumor Budding).
Researchers will retrospectively analyze tissue samples (paraffin blocks) from at least 100 patients who were diagnosed with urothelial bladder carcinoma and underwent transurethral resection (TUR) at the South Egypt Cancer Institute between 2018 and 2024.
The tissue samples will be analyzed in two main ways:
By comparing these detailed microscopic measurements with the patients' historical medical records, the study hopes to determine if T1 substaging and Tumor Budding are strong predictors of disease recurrence, disease progression, and overall patient survival.
Bladder carcinoma remains a major global oncological burden, exerting a substantial impact on patient morbidity and mortality. In Egypt, it constitutes a significant public health concern with distinctive epidemiological characteristics. While squamous cell carcinoma historically predominated, a substantial shift has occurred over recent decades, and urothelial carcinoma has emerged as the dominant subtype, accounting for approximately 75-80% of cases.
Pathological assessment traditionally focuses on histological grade and invasion depth. The precise assessment of invasion depth is critical, particularly in T1 non-muscle-invasive urothelial carcinoma, where the tumor invades the lamina propria. Multiple sub-classification systems exist for T1 tumors, including anatomical approaches relative to the muscularis mucosae and semiquantitative micrometric methods, yet no single method has been adopted universally. Furthermore, in muscle-invasive disease, the morphology of the invasive front provides crucial biological insights. Tumor budding, defined as single isolated cancer cells or small clusters of fewer than five cells at the invasive front, is recognized as a morphological hallmark of epithelial-mesenchymal transition (EMT) and reflects aggressive tumor potential.
This study evaluates archived hematoxylin and eosin (H\&E)-stained slides from patients who underwent transurethral resection (TUR) for urothelial carcinoma between 2018 and 2024. Histological subtypes will be confirmed according to the 2022 World Health Organization (WHO) classification, and tumor grade and stage will be determined using the American Joint Committee on Cancer (AJCC) 8th edition. Additional pathological parameters assessed will include tumor size, multifocality, coagulative tumor necrosis, lympho-vascular invasion (LVI), and perineural invasion (PNI).
The histopathological procedures are divided into two primary evaluations:
294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.
This study's planned enrollment of 100 is below the median of 300 across 49 observational studies indexed under Non-Muscle Invasive Bladder Neoplasms.
Browse Non-Muscle Invasive Bladder Neoplasms studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Compared within Non-Muscle Invasive Bladder Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Bladder Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
The study population consists of patients diagnosed with urothelial bladder carcinoma who underwent transurethral resection (TUR) at the South Egypt Cancer Institute (SECI), Assiut University, between the years 2018 and 2024. The study utilizes retrospectively collected, archived paraffin-embedded tissue blocks along with corresponding clinical, pathological, and survival data retrieved from medical records and electronic pathology reports.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All confirmed pT1 cases will undergo rigorous histopathological substaging. An anatomical substaging (T1a/b/c) will be performed by identifying the level of invasion relative to the muscularis mucosae. Additionally, micrometric assessment will be carried out using a 0.1 mm threshold and the Rete Oncologica Lombarda (ROL) system.
These cases will be evaluated for Tumor Budding. The "Hotspot" method will be used to count buds in one high power field at the invasive front. Cases will be graded as Low Budding (BD1): 0-4 buds, Intermediate Budding (BD2): 5-9 buds, and High Budding (BD3): ≥ 10 buds.
Overall Survival (OS)
Overall survival is defined as the length of time from the date of the transurethral resection (TUR) to the date of death from any cause. This outcome will be correlated with the assessed histopathological parameters (T1 substaging and Tumor Budding scores) to evaluate their prognostic significance in urothelial bladder carcinoma.
Time frame: Up to 72 months (retrospectively assessed spanning the 2018 to 2024 study period).
No study locations are listed for this record.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Non-Muscle Invasive Bladder Neoplasms →